Myocarditis AcutePREMYONCT06898762
Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort
An observational study of Myocarditis Acute and Inflammatory Cardiomyopathy, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial summary
The objectives of this project are: 1) to comprehensively characterize a large national cohort of patients with suspected myocarditis, their clinical phenotype, care management, blood and imaging biomarkers, epidemiological, environmental and genetic data; 2) to retrospectively validate the accuracy of the new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis Acute, Inflammatory Cardiomyopathy
- What is being tested?
- characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2023to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with clinical suspicion of myocarditis or inflammatory cardiomyopathy will be included, based on the presence of compatible clinical findings.
Who may be able to join
- Presence of at least one compatible symptom and at least one objective finding in diagnostic tests (Figure 2), according to the consensus document of the European Society of Cardiology (1):
- Clinical presentation:
- Acute chest pain: pericardial or pseudo-ischemic.
- Dyspnea on exertion or at rest for up to 3 months.
- Dyspnea on exertion or at rest for 3 months - 1 year.
- Unexplained palpitations / arrhythmias, sudden death recovered.
Show all 12Show fewer
- Unexplained cardiogenic shock.
- Findings in complementary tests:
- ECG: new onset AV block, new onset bundle branch block, ST segment elevation/depression, T wave inversion
- Elevation of TnI/TnT
- Segmental or global contractility alterations not explained by other causes
- Positive Lake Louise criteria in cardiac MRI (13) (Annex III Figure S1) • Patients who have given their informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
HCUVA
Murcia, Murcia, 30120
Domingo Pascual Figal, MD, 868885273, coordinacion@premyo.org
About this study
The objectives of this project are: 1) to comprehensively characterize a large national cohort of patients with suspected myocarditis, their clinical phenotype, care management, blood and imaging biomarkers, epidemiological, environmental and genetic data; 2) to retrospectively validate the accuracy of the new hsa-RNA-Chr8:96 biomarker for the diagnosis of myocarditis compared to conventional diagnosis; 3) to identify acquired and inherited mutations, and their interaction with the environment, which explain the susceptibility to myocarditis, its severity and response to treatment; 4) to study the lower incidence in women and the influence of age, considering socio-health and genetic factors.
Read the detailed description
The primary endpoint of the study will be the characterization of a broad national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy. The secondary endpoints of the study will be (A) individual susceptibility to developing myocarditis or inflammatory cardiomyopathy, 1) identifying acquired and inherited genetic variants, and 2) from the persistence of gender, age, and socioenvironmental conditions; and (B) studying the correlation between the final diagnosis of myocarditis and the hsa-miR-Chr8:96 marker.
- Conditions
- Myocarditis Acute, Inflammatory Cardiomyopathy
- Being tested
- characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.Other
characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.
What is being measured
The primary outcome is the main question the study is designed to answer.
characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.
Subjects will be recruited during an emergency room visit or within their usual clinical practice among those patients who meet the criteria for participation in the study.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start9 Apr 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Domingo Pascual Figal, MD, Principal investigator, HCUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898762
- Sponsor's protocol ID
- 2023-5-2-HCUVA
- Acronym
- PREMYO
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort
- ClinicalTrials.gov ID
- NCT06898762
- Acronym / sponsor ID
- PREMYO / 2023-5-2-HCUVA
- Conditions
- Myocarditis Acute, Inflammatory Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Study start
- 9 Apr 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this project are: 1) to comprehensively characterize a large national cohort of patients with suspected myocarditis, their clinical phenotype, care management, blood and imaging biomarkers, epidemiological, environmental and genetic data; 2) to retrospectively validate the accuracy of the new hsa-RNA-Chr8:96 biomarker for the diagnosis of myocarditis compared to conventional diagnosis; 3) to identify acquired and inherited mutations, and their interaction with the environment, which explain the susceptibility to myocarditis, its severity and response to treatment; 4) to study the lower incidence in women and the influence of age, considering socio-health and genetic factors.
Detailed description
The primary endpoint of the study will be the characterization of a broad national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy. The secondary endpoints of the study will be (A) individual susceptibility to developing myocarditis or inflammatory cardiomyopathy, 1) identifying acquired and inherited genetic variants, and 2) from the persistence of gender, age, and socioenvironmental conditions; and (B) studying the correlation between the final diagnosis of myocarditis and the hsa-miR-Chr8:96 marker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with clinical suspicion of myocarditis or inflammatory cardiomyopathy will be included, based on the presence of compatible clinical findings.
Key inclusion criteria (12 listed)
- Presence of at least one compatible symptom and at least one objective finding in diagnostic tests (Figure 2), according to the consensus document of the European Society of Cardiology (1):
- Clinical presentation:
- Acute chest pain: pericardial or pseudo-ischemic.
- Dyspnea on exertion or at rest for up to 3 months.
- Dyspnea on exertion or at rest for 3 months - 1 year.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy. | Other | – |
Primary outcome
characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy.
Time frame: Up to 3 years
Subjects will be recruited during an emergency room visit or within their usual clinical practice among those patients who meet the criteria for participation in the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Domingo Pascual Figal, MD principal investigator
HCUVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis Acute and Inflammatory Cardiomyopathy, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domingo Pascual Figal, MD (868885273, coordinacion@premyo.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterization of a large national cohort of patients with suspected myocarditis or inflammatory cardiomyopathy. (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.